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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K870979
Device Name HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS
Applicant
Inventory Supply Corp.
1633 E. Lincoln Ave.
Orange,  CA  92665
Applicant Contact HOWARD D BALSHAN
Correspondent
Inventory Supply Corp.
1633 E. Lincoln Ave.
Orange,  CA  92665
Correspondent Contact HOWARD D BALSHAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/10/1987
Decision Date 06/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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